Analysis of the importance of drug packaging quality for end users and pharmaceutical industry as a part of the quality management system

摘要

In this study, we collected and analyzed information on the importance of drug packaging quality to end users and pharmaceutical industry, as an indicator of the process of traceability and originality of drugs. Two surveys were conducted: one among the end users of drugs (252 patients) and the other among professionals working in seven pharmaceutical companies in Serbia. For most end users (82.5%) quality on the packaging of drugs was important, but only 41.8% of them thought that the appearance of the packaging could be an indicator of genuinity of drugs. The existence of the control marks (KM) on drug packaging was not of great importance, since most of them (86.9%) know, its function, but majority (60.2%) would nevertheless decide to buy the drug without KM. Regarding the experts from the pharmaceutical industry, more then two-thirds of them (68.4%) believed that the existence of KM did not contribute to efficient operations. Although a great number of pharmaceutical industry professionals (84.2%) answered that the introduction of GS1 DataMatrix system would allow for complete traceability of the drug from the manufacturer to the end user, only 22.2% of them introduced this system to their products. This study also showed that domestic producers did not have a great interest for additional protection (special inks, holograms, special graphics, smart multicolor design, watermark, chemically labeled paper and cardboard etc..) on their products, given that only 15.8 % of them had some kind of additional protection against counterfeiting. Monitoring drug traceability from a manufacturer to end user is achieved by many complex activities regulated by law. A high percentage of responders said they were satisfied with the functionality of traceability systems used in their companies. As a way to increase the quality of drug packaging and business performance most responders saw in the continuous improvement of the system of traceability within the company's overall quality management system. For them, a big financial investment in the complete traceability chain was not feasible because of the inability to achieve competitive prices in the market. Since only three of surveyed companies were part of international chains, these findings open the path for new research that would include more multinational drug manufacturers from the region, in order to fully comprehend the importance of investing in the drug chain traceability and protection against counterfeiting, as a part of total quality management process in the pharmaceutical industry. [Projekat Ministarstva nauke Republike Srbije, br. 179001]